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Penlon AV-S Ventilator - Service Manual PDF
Penlon AV-S Ventilator - Service Manual PDF
Technical Support
Penlon Limited
Abingdon Science Park
Barton Lane
Abingdon
OX14 3PH
UK
1. Type of equipment
2. Product name
3. Serial number
4. Approximate date of purchase
5. Apparent fault
(i)
FOREWORD
(ii)
CONTENTS
Page No.
USER RESPONSIBILITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1. WARNINGS AND CAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
2. PURPOSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3. DESCRIPTION
3.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.2 Ventilation Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4. SPECIFICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Ventilator .................................................. 34
Oxygen Monitor . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
(iii)
CONTENTS
5. PRE-OPERATION PROCEDURES
5.1 Ventilator Set-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
5.1.1 Mounting the Ventilator ....................................... 39
5.1.2 Electrical Power Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
5.1.3 Ventilator Gas Supply .................................. 39
5.1.4 Breathing System Schematic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
5.1.5 Bellows Drive Gas ........................................... 43
5.1.6 Anaesthetic Gas Scavenging System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
5.1.7 Remote Screen ........................................... 43
5.1.8 Printer .................................................... 43
5.1.9 Breathing System ........................................... 44
5.1.10 Spirometer Connections ....................................... 44
5.1.11 Pressure Monitor Connections .................................. 46
5.1.12 Bellows Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
6. SERVICE PROCEDURES
6.1 Service Intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
6.2 Control Unit Patient Block Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
6.3 Valve Calibration ........................................... 56
7. SERVICE SCHEDULE
Service Schedule ..................................... 57
8. PARTS LISTS
Preventive Maintenance Kits .............................. 66
Assemblies ...................................... .... 67
9. APPENDIX
1. Back-up Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
2. Menu System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
3. Ventilator Spirometry System .......................... .... 82
4. Cleaning / Sterilisation / Oxygen sensor replacement . . . . . . . . . . . . . . . . . 85
5. Software Upgrade Installation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . 89
6. Calibration and Output Checks for a New Ventilator . . . . . . . . . . . . . . . . . . . 90
7. Menu structure amendments (v1.86.01 / .02 / .04) . . . . . . . . . . . . . . . . . . . . 94
(iv)
USER RESPONSIBILITY
This anaesthesia ventilator has been built to Statements in this manual preceded by the
conform with the specification and operating following words are of special significance:
procedures stated in this manual and/or
accompanying labels and notices when WARNING means there is a
checked, assembled, operated, maintained possibility of injury to the
and serviced in accordance with these user or others.
instructions.
CAUTION means there is a possibility
To ensure the safety of this device it must be of damage to the apparatus
checked and serviced to at least the or other property.
minimum standards laid out in this manual.
A defective, or suspected defective, product NOTE indicates points of
must not under any circumstances be used. particular interest for more
efficient and convenient
The user must accept responsibility for any
operation.
malfunction which results from non-
compliance with the servicing requirements
detailed in this manual. Always take particular notice of the
warnings, cautions and notes provided
Additionally, the user must accept throughout this manual.
responsibility for any malfunction which may
result from misuse of any kind or non-
compliance with other requirements detailed
in this manual.
1
1. WARNINGS AND CAUTIONS
The following WARNINGS and CAUTIONS 7. The driving gas is discharged through
must be read and understood before using the opening in the back of the ventilator
control unit.
this ventilator.
The discharged gas may contaminate
the environment, and should therefore
be extracted using a gas scavenging
WARNINGS system.
General Information
8. The bellows can only support
1. Personnel must make themselves approximately 1 kPa (10 cmH2O)
familiar with the contents of this differential positive pressure, above
manual and the machines function which it may be dislodged from the
before using the ventilator. mounting ring, resulting in dangerous
malfunction of the ventilator.
Do not connect a positive end
Before Using the Ventilator expiratory pressure (PEEP) valve or
2. Before the ventilator is used clinically other restrictive device to the exhaust
for the first time, verify that the hospital port on the bellows base.
engineering department has carried out This would increase the pressure inside
an earth continuity test. the bellows and the bellows could
detach from the base, causing serious
3. Excessive electronic noise caused by malfunction.
other poorly regulated devices, such as
an electrocautery unit, may adversely 9. Breathing System
interfere with the proper functioning of The breathing system which conveys
the ventilator. gases from the anaesthetic machine to
the patient, and disposes of expired
To avoid this problem, do not connect gases, must conform to the
the ventilators power cord into the requirements of ISO 8835-2.
same electrical wall outlet or adaptor Because breathing systems require
strip into which an electrocautery unit frequent cleaning and disinfection they
is connected. are not a permanent part of the
anaesthetic ventilator and therefore
4. If used with a mains extension cord, the cannot be directly under the control of
unit may be subject to electro-magnetic the anaesthetic ventilator manufacturer.
interference. However, we strongly recommend that
only breathing systems which have
5. The driving gas supply must be clean been approved and authorised by the
and dry to prevent ventilator manufacturer for use with AV-S should
malfunction. be employed.
2
WARNINGS AND CAUTIONS
11. The operation of each alarm function 17. When the ventilator is connected to a
should be verified daily. patient, it is recommended that a
qualified practitioner is in attendance
Periodically check the alarms at at all times to react to an alarm or other
clinically suitable intervals. If the indication of a problem.
audible alarm or the visual indicator of
any alarm function fails to activate 18. In compliance with good anaesthesia
during any alarm condition or fails to practice, an alternative means of
reset after the alarm has been cleared, ventilation must be available whenever
refer the unit to an authorised service the ventilator is in use.
technician.
19. It is recommended that the patient
12. Before using the ventilator check that oxygen concentration should be
all connections are correct, and verify monitored continuously.
that there are no leaks.
20. If the drive gas supply pressure drops
Patient circuit disconnects are a hazard below a nominal 241 kPa (35 psi), the
to the patient. Extreme care should be LOW DRIVE GAS SUPPLY alarm will
taken to prevent such occurrences. activate both audibly and visually.
Patient minute volume may be reduced
It is recommended that Safelock due to lowered flow rates
fittings are used throughout the
breathing circuit. 21. An audible alarm indicates an
anomalous condition and should never
13. Check that the cable between the go unheeded.
control unit and remote display screen
unit is connected before use. 22. The characteristics of the breathing
Always use a cable type recommended circuit connected between the
by the manufacturer. ventilator and the patient can modify or
change patient ventilation.
Using the Ventilator To assist the maintenance of the
delivered patient tidal volume, the
14. The AV-S ventilator is not intended for ventilator control system software
use in intensive care applications. includes:
A) a compliance compensation
15. This apparatus must not be used with, algorithm,
or in close proximity to, flammable B) a fresh gas compensation
anaesthetic agents. algorithm.
There is a possible fire or explosion
hazard. However, patient ventilation must be
monitored independently from the
16. Anaesthesia apparatus must be ventilator.
connected to an anaesthetic gas It is the responsibility of the user to
scavenging system (AGSS) to dispose monitor patient ventilation.
of waste gas and prevent possible
health hazards to operating room staff. 23. Care must be taken to ensure that the
This requirement must be observed flow sensors are connected correctly
during test procedures as well as to the inspiratory and expiratory ports
during use with a patient. of the absorber.
The scavenging transfer and receiver
system must conform to ISO 8835-3. 24. The Vent Inop (ventilator inoperative)
Any problem arising from an alarm indicates that one of the
improperly functioning scavenging following conditions has occurred:
system is solely the users a) The drive gas solenoid has failed.
responsibility.
Do not use a scavenging system that b) The flow control valve has failed.
restricts drive gas flow when negative c) Internal electronic fault.
pressure is exerted on it.
d) Internal electrical fault.
e) Software error.
3
WARNINGS AND CAUTIONS
Note that if a ventilator error is 31. Exterior panels must not be removed
detected, Ventilator Inoperative will be by unauthorised personnel and the
displayed on the front control panel apparatus must not be operated with
display. such panels missing.
There is a possible electric shock
25. The High and Low Airway Pressure hazard.
Alarms are important for patient care.
It is important that the sensor is Bellows Assembly
properly located in the expiratory limb
32. The valve seat on the patient gas
of the circuit - refer to section 5.1.10.
exhalation diaphragm valve in the base
of the bellows assembly must be
26. The patient must be continuously cleaned regularly. Note that the bellows
attended and monitored when assembly is built into the A200SP
Advanced Breathing Modes are in use. Absorber - please refer to User Manual
for this product.
Failure to keep the valve seat clean
User Maintenance
could result in the diaphragm sticking,
thus preventing exhalation.
Control Unit
27. Opening the control unit by
Great care must be taken not to
unauthorised personnel automatically
damage the precision surface of the
voids all warranties and specifications.
valve seat on the patient gas exhalation
diaphragm valve in the base of the
Prevention of tampering with the
bellows assembly.
control unit is exclusively the users
responsibility. If the control unit seal is
Never use any hard object or abrasive
broken, the manufacturer assumes no
detergent to clean it; use only a soft
liability for any malfunction or failure of
cloth.
the ventilator.
If the valve seat is damaged, the valve
will leak and may cause serious
28. For continued protection against fire
ventilator malfunction.
hazards, replace the two fuses only
with the identical type and rating of
fuse.
See section 4 for fuse rating.
4
WARNINGS AND CAUTIONS
CAUTIONS
NOTES
1. Do not sterilise the ventilator control unit.
The patient block assembly must be 1. The term cycle is used to designate the
removed from the control unit before transition to the exhalation phase.
sterilisation ( see section 6.2.5).
All other internal components are not 2. The term trigger is used to indicate the
compatible with sterilisation techniques transition to the inhalation phase.
and damage may result.
5
WARNINGS AND CAUTIONS - Oxygen Monitor
Oxygen Monitor
NOTES
1. The O2 SENSOR FAULT alarm indicates
Note that the sensor for the oxygen that one of the following conditions has
monitor is built into the A200SP occurred.
Absorber - for additional information, a) Internal electrical fault
please refer to the A200SP User b) Software/electronics fault
Manual. c) Oxygen sensor fault.
3. ALWAYS check the integrity of the 5. Fresh gas mixture compensation is disabled
sensor assembly before use. if the oxygen monitor is switched OFF.
CAUTIONS
1. Do not sterilise any oxygen monitor
component.
Oxygen Monitor
The Oxygen Monitor is intended to
continuously measure and display the
concentration of oxygen in breathing gas
mixtures used in anaesthesia, and is
intended for adult and paediatric patients.
The oxygen monitor is an integral part of the
ventilator.
The oxygen monitor is intended for use by
health care providers, i.e. Physicians,
Nurses and Technicians for use with patients
during general anaesthesia.
7
3. DESCRIPTION
Screen
Remote, arm-mounted, 210 mm (8.4 inch) high
definition, colour TFT screen, with single/dual
waveform display.
Bellows unit
The bellows unit (1) is built into the A200SP
absorber. A paediatric bellows assembly is
available as an option
5 8 9 10 11 12 13 14 15
6
3 2 1
7
4
NOTE
USB port is for access only by engineers
trained by the manufacturer.
All other data ports are read only.
For further information, please contact
your distributors service department, or
the manufacturer.
9
DESCRIPTION
1. Inspiratory Phase
2. Beginning of
Expiratory Phase
1
The drive gas proportional
valve (1) closes.
4 The patient proportional
valve (3) closes.
The exhaust valve (4) opens.
3
Patient gas returns to the
5 bellows (5).
As the bellows rises,
redundant drive gas is
pushed out through the
exhaust valve.
10
DESCRIPTION
3. End of
Expiratory Phase
4
With the bellows at the top
of its housing fresh gas
continues to flow.
5 To prevent a high pressure
build up the exhalation
6 diaphragm (6) lifts and
allows gas to exit through
the exhaust valve (4).
4. PEEP
Positive End
Expiratory
1 Pressure
(user selectable)
11
DESCRIPTION
A Pneumatic Flow
Diagram
1 3 to 7 bar
2
3 241 kPa (35 psi)
5 6
0 - 80 cmH2O
B 7 8 14
C
10 12
11 15
0 - 90 cmH2O
13
16
100 cmH2O
17 18
12
DESCRIPTION
The AV-S Ventilator is designed to operate on a 310 - 689 kPa (45 -100 psi)
drive gas supply (oxygen or air - to customers requirement).
1. DISS Connector
The gas source is connected to the DRIVE GAS SUPPLY fitting on the
rear of the ventilator control unit.
The gas supply should be capable of a flow rate of 80 L/min while
maintaining a minimum pressure in excess of 310 kPa (45 psi).
2. Filter
The drive gas is filtered with a 40-micron Input Gas Filter which protects
the pneumatic components from incoming particulate matter.
5. Cut-off Valve
The valve isolates the the gas supply :
a) when the ventilator is switched off
b) when a fault condition occurs.
13
DESCRIPTION
Mains Supply
The mains supply inlet is designed for
connection to any mains voltage from 100 to
240 VAC and a frequency of 50 to 60 Hz,
without any adjustment.
The connector is a standard IEC type.
Back-up Battery
In the event of mains electrical failure, the back-
up battery cuts in automatically.
Standard battery:
A fully charged battery will power the ventilator
for approximately 30 minutes.
14
DESCRIPTION
2
AV-S
Gas Mixture 1
.
cm H2O
.
O2 + air o IO
o
%O2 100
SMMV
33 20
4
Trigger
Freeze
cmH2O
Waveform
-1.0
Pmax Pmean
3
cmH2O cmH2O
24 10 5
Spont
secs Mode
3.6 3.6 6 2 5 38
Touchscreen control
15
DESCRIPTION
16
DESCRIPTION
I:E Ratio
1:6 1:5 1:4 1:3 1:2 1:1 1:0.3
1.6
1.5
1.4
1.3
1.2
1.1
1.0
Tidal
Volume 0.9
(litres) 0.8 X
(Vt) 0.7
0.6
0.5
0.4
0.3
0.2
0.1
0 10 20 30 40 50 60 70 80
Rate (bpm)
Example
1. Select required volume (Vt) (e.g. 0.8 L)
2. Select rate (e.g. 10 bpm).
3. Select I:E ratio of 1:2.
The point X on the graph lies beneath the 1:2 ratio curve, and is therefore within the
ventilators capability.
17
DESCRIPTION
WARNING
The AV-S automatically compensates for fresh
gas (spirometry On), fresh gas mixture
(spirometry and oxygen monitor On), and
altitude.
However, the actual tidal volume delivered to the
patient may be different to the ventilation
parameters set by the user, due to:
A) an extreme compliance condition,
B) a substantial system leak,
C) patient circuit pressure effects, or
D) extreme fresh gas flows
NOTE
Fresh gas compensation is disabled if :
a) The spirometry system is turned OFF through the
menu system, or
b) The spirometry system is not functioning correctly.
NOTE
Fresh gas mixture compensation is disabled if :
a) The spirometry system is turned OFF through the
menu system, or
b) The spirometry system is not functioning correctly.
Altitude Compensation
This function monitors ambient pressure, and
adjusts the delivered volume accordingly
NOTE Altitude compensation is automatically
applied during calibration of the oxygen monitor - see
section 5.3.2.
18
DESCRIPTION
ii) Ventilator in Spontaneous Mode B) If the ventilator was in Standby Mode and
Switching the absorber Bag/Vent control Spontaneous Mode selected on-screen:
from Bag to Vent - the ventilator will default to Volume Mode.
A) If the ventilator was previously in Volume, or C) If the ventilator was put into Standby Mode
Pressure, or Special Mode, and Spontaneous after automatic mode switching to Spontaneous:
Mode was automatically selected by the - the ventilator will default to Volume Mode.
19
DESCRIPTION
20
DESCRIPTION
Sigh function:
When the ventilator is in Volume Cycle mode the
"Sigh" option is available. When selected, this
option provides extra volume for 1 to 4 breaths in
50 (the user can select 1, 2, 3, or 4 breaths).
The extra volume will be approximately 50% above
the tidal volume set by the user.
Note that the High Volume Alarm is not triggered
when sigh is selected.
Volume measurement:
Volumes are measured if the Spirometry function is
selected.
Automatic High or Low volume alarms are
triggered if the measured volume is 50% above or
below the set volume.
21
DESCRIPTION
3.7.3.1 Parameters
In pressure mode the ventilator delivers a flow
of gas to achieve a set pressure at fixed
breath intervals.
The Patient is making no respiratory effort.
This is a common mode for the ventilation of
small paediatric patients.
22
DESCRIPTION
3.7.4.1 Parameters
The ventilator monitors the following patient parameters:
Rate
I:E ratio
Pressure
Tidal volume
Functions
No mechanical ventilation
No Inspiratory Pause function
23
DESCRIPTION
Note:
1. Vt can be adjusted before SIMV is
confirmed.
2. The trigger setting is adjustable
between 0.7 and 4.0 L/min.
24
DESCRIPTION
3.7.5.2 SMMV
Synchronised Mandatory C E
Minute Ventilation D
SMMV Default Settings If the patient makes no effort to breathe during a cycle, a
mandatory breath, at the end of the trigger window, will still be
The ventilator will default to pre-set values delivered at the preset volume and rate
for minute volume (Vm), Rate, Inspiratory
Time and Trigger Level, after selecting
'SMMV'.
Note:
1. Vm can be adjusted before SMMV is
confirmed.
2. The trigger setting is adjustable
between 0.7 and 4.0 L/min.
25
DESCRIPTION
3.7.5.3 PSV
Pressure Supported B
Ventilation
PSV assists each spontaneous breath to
achieve a preset pressure, thus reducing the
effort required to breathe.
Inspiratory flow (generated by the patients
spontaneous breath) results in synchronised
pressure support. PEEP
0 cmH2O
A A
PSV must be pre-selected in Standby
mode
Select Standby Mode C C
Select Menu
Select Special Modes PSV Pressure Supported Ventilation
A = Set Inspiratory Time
Select Support Mode
B = Pressure Support Level
Select PSV
C = Spontaneous Breath results in a synchronised pressure supported breath
Escape Menu
PSV is used to support spontaneously breathing patients ONLY
PSV will be displayed on the main screen If the patient makes no attempt to breathe, the ventilator will not
when Spontaneous mode is selected or provide support and the apnoea alarm will be activated
triggered.
NOTE
1. The trigger window is pre-set to 60% of
the BPM cycle time.
2. The trigger pressure is PEEP referenced.
3. If the Spirometry system is disabled, then
PSV is not available.
4. If the pressure limit and alarm are
activated the inspiratory phase is
terminated.
Note:
1. Support Pressure can be adjusted
before PSV is confirmed.
2. The trigger setting is adjustable
between 0.7 and 4.0 L/min.
26
DESCRIPTION
NOTE
1. PEEP is electronically controlled
2. PEEP is variable from 4-20 cmH2O, in increments of 1
cmH2O
3. The display shows OFF when PEEP is not in use
4. PEEP is switched off when the ventilator is switched off.
5. PEEP is switched off during 'Spont' mode to minimise
patients breathing effort.
Selecting PEEP
1. Select by touching the screen tab PEEP, or using the
navigator wheel
The setting will flash.
2. Rotate the navigator wheel to set the required PEEP
pressure.
A confirm message will be displayed.
3. Press the Screen Tab, or Wheel to confirm.
To Access:
Press the menu switch on the front panel to access
the following functions and parameters via drop-
down menus:
EXIT MENUS
O2 MONITOR & SPIROMETRY
FRESH GAS COMPENSATION: ON
SPECIAL MODES Menu Switch
WAVEFORM
ALARM SETTINGS
GAS MIXTURE: O2+AIR
USER SETTINGS
SERVICE MENU
Turn the wheel
To Exit: to scroll through
Press the menu switch on the front panel, or, select the menus.
EXIT MENUS and press the wheel. Press to enter
sub-menu
NOTE
The menu window will not be displayed if:
A) Control parameters (VT MEAS, BPM, I:E, PEEP, or
LIMIT) are enabled but not confirmed.
B) A display window is active
To Operate:
1. Rotate the navigator wheel clockwise to scroll
through the menu options - the cursor ( > )
aligns with each parameter in turn.
2. Press the wheel to enter the required sub-
menu.
3. Rotate the navigator wheel to change any
displayed values, and press to confirm.
4. To exit the menu display:
A) Press the menu switch on the front panel
B) Scroll to EXIT MENUS,
and press the navigator wheel.
NOTE
A) If confirmation does not take place within 8
seconds, the parameter reverts to its previous
value.
B) If another parameter is selected using the
touchscreen, the menu is de-selected.
C) While any menu is selected:
- the alarms are active,
- the ventilator can be switched off.
28
DESCRIPTION
3.9 Spirometry
Second waveform
The second waveform can be displayed by
using the menu control or by touching the
waveform on screen.
Select from:
Volume v Time (litres v seconds)
Volume v Pressure (litres v cmH2O)
Compliance loop waveform
- First loop can be frozen
- Subsequent loops overlaid
Y axis
a) The scale adjusts as Plimit is changed
(-20 to 40, 60, 80 cmH2O)
b) In Vol. v Time mode the scale adjusts as
Vt is changed
(0 to 0.5 L, 1.0 L, 2.0 L)
X axis
a) The scale adjusts as Rate is changed
(0 to 15 sec, 5 sec, 3 sec)
b) In Vol. v Pres. mode the scale adjusts as
Plimit is changed (-20 to 40, 60, 80
cmH2O)
29
Alarm Priority Trigger Mute Set by:
time
3.11
NOTE
Ventilator Inoperative (vent inop) High Internal failure or Battery failure zero Automatic
Outlet blocked High Positive pressure exceeds 120 cmH2O, due to blocked exhaust valve outlet zero Automatic
Power About to Fail High Ventilator is using the battery, and the battery voltage is less than 10.2 v zero Automatic Alarms
Low Drive Gas Supply Pressure High Less than 235 kPa (35 psi +/-1 psi) zero Automatic
Low Bellows Drive Gas Pressure High Fails to reach target level 30 s Automatic
High Bellows Drive Gas Pressure High Exceeds calculated target level 30 s Automatic
High Continuous Airway Pressure High Breathing system pressure fails to return to below 30 cmH2O 120 s Auto
by the start of the next inspiratory phase
DESCRIPTION
High Airway Pressure High Pressure reaches set limit (10 to 80 cmH2O adjustable) 30 s User / Default
Low Airway Pressure High Breathing system pressure fails to reach minimum level (14 to 14 cmH2O) 120 s Automatic
Negative Airway Pressure High Breathing system pressure exceeds 10 cmH2O 120 s Automatic
Low Tidal Volume (Vt) High a) Measured Vt less than 50% of volume set 120 s User / Default
b) Spirometer disconnected
30
Low Minute Volume (Vm) High Calculated volume lower than 50% of volume set 120 s User / Default
Apnoea High In Spontaneous mode, no breath detected within 15 seconds 120 s Automatic
the front panel (see 3.8), and select ALARM SETTINGS.
High Tidal Volume (Vt) High Measured value exceeds 150% of set value 120 s User/Default
High Minute Volume (Vm) High Calculated value exceeds 150% of set value 120 s User / Default
High O2 Concentration High Measured O2 % exceeds set value 120 s User / Default
Low O2 Concentration High Measured O2 % lower than set value 120 s User / Default
O2 Sensor low output Low Sensor life exhausted zero Automatic
O2 sensor fault High Sensor disconnected 120 s Automatic
Printer not available Low Printer disconnected, or has no power, or has no paper zero
Priority identification:
High Priority: Five ascending tones - repeated Medium Priority: Three ascending tones - repeated Low Priority: Single tone - repeated
DESCRIPTION - O2 Monitor
Bacterial Filter
Always use a breathing system bacterial filter in the
expiratory limb of the breathing circuit to protect the
oxygen sensor and breathing system components
from contamination (see section 5).
CAUTION
Replacement/Disposal - always follow the instructions
supplied with the filter, and always replace at the
recommended interval.
1
3.12.2 The Oxygen Sensor
The oxygen sensor offers quick response, linear output
over the entire 0-100% oxygen range, and long service
life.
The cell has a highly stable output over its operating life.
Significant output loss is only shown at the very end of its
life.
Typical sensor drift rates are less than 1% per month when
the sensor is exposed to gas in typical applications.
Sensor life:
approximately 1500 000 O2% hours at 20oC
(minimum one year in most normal applications).
At the point where all lead has been consumed, the output
will fall very quickly to zero over a period of two to three
weeks.
31
DESCRIPTION
O2 Monitor sub-menu
ON/OFF
Turn the navigator wheel to switch between
O2 Monitor & Spiro
ON and OFF.
Press to confirm.
ESCAPE FROM MENU
Scroll to EXIT MENUS and press the wheel
> O2 MONITOR: on
to exit.
CALIBRATION: 100%
NOTE
HIGH ALARM SET: 105
The oxygen monitor automatically switches ON LOW ALARM SET: 18
and defaults to the previous values for high and SPIROMETER: on
low alarm settings when the ventilator is SPIRO CALIBRATION: 0 L/min
switched on.
Fresh gas mixture compensation is disabled if the
O2 monitor is switched OFF.
32
DESCRIPTION - O2 Monitor
Oxygen Concentration
The display provides a direct readout of
measured oxygen concentrations in the range
o
o .
IO
.
0-100%. %O2 100
33 20
Low Alarm Set - limited within 18-99%
The oxygen percentage, set by the user, at
which the low alarm will be activated.
Measured O2 Low Alarm Set Value
To set the low oxygen alarm, see section 5.3.4.
concentration
High Alarm Set - limited within 19-105%
The oxygen percentage, set by the user, which
the high alarm will be activated.
Note that in certain conditions of excess
pressure, the readout may show a value above
100%.
To set the high alarm, see section 5.3.4.
a) The message O2 SENSOR FAULT will be b) When O2 concentration drops below 18%.
displayed.
33
4. SPECIFICATION
4.3 Physical
Size (mm)
- control unit only 290 wide x 300 deep x 185 high
- with adult bellows 290 wide x 300 deep x 385 high
Screen Size 210 mm (8.4") TFT
Weight - control unit only 7.6 kg
- with adult bellows 9 kg
Bellows
Adult (Latex free): 20 ml - 1600 ml
Paediatric : 20 - 350 ml
(Note - latex free paediatric available as option)
4.4 Alarms
Alarm Mute 30 or 120 seconds (see 3.11)
Apnoea Flow referenced (no breath detected within 15 seconds)
Low Drive Gas Pressure Less than 235 kPa (35 psi)
High Continuous Airway Pressure Above 30 cmH2O at start of cycle
Low Pressure 4 - 14 cmH2O PEEP referenced
Incorrect Rate or Ratio
Mains Failure Fully charged standard battery provides 30 mins (nominal)
backup
Fully charged high-power battery (option) provides one
hour (nominal) backup
Low Battery 5 minutes use
Ventilator Inoperative Internal or Battery Failure
Outlet Blocked Exhaust valve outlet blocked
Alarms - User Adjustable
Low Tidal Volume Measured value is below 50% of volume set
Range: 0 - 1600 ml
High Tidal Volume Measured value exceeds 150% of volume set
Range: 20 - 1600 ml
Low Minute Volume Calculated value is 50% below volume set
Range: 0 - 10 L
High Minute Volume Calculated value exceeds 150% of volume set
Range: 0 - 30 L
Low and High O2 Concentration 18% - 105%
High Airway Pressure 10 - 80 cmH2O adjustable
34
SPECIFICATION
4.5 Functional
Tidal Volume
Adult bellows 20 to 1600 ml (10%)
Paediatric bellows 20 to 350 ml (10%)
At ambient temperature of 20oC (+/-10%) and ambient atmosphere of 101.3 kPa (+/-10%).
Minute Volume 0 to 30 L
Rate 4 - 100 bpm
I:E Ratio 1:0.3 - 1:8
Pressure Limit 10 - 100 cmH2O
Fresh Gas Compensation Automatic Tidal Volume adjustment
Modes Off
Standby
Volume Cycle
Pressure Controlled
Spontaneous (includes advanced breathing modes)
Spirometry - Resolution 10 ml
NOTE
The ventilator is designed for use with Spirometry ON.
Accuracy of delivered volumes with Spirometry OFF may vary from the figures given above.
35
SPECIFICATION
36
SPECIFICATION - O2 Monitor
Accuracy and Linearity: 2% of full scale (at constant temperature and pressure)
Response Time: 90% of final value in approximately 10 seconds
(air to 100% O2)
High Priority Alarm: Flashing, 5 audio pulses with 6 seconds repeat time.
Medium Priority Alarm: Flashing, 3 audio pulses with 24 seconds repeat time
Low Priority Alarm: Static with single beep sound
Alarm Mute: 30 seconds for high priority alarm
120 seconds for medium priority alarm
Sensor
Type: Galvanic fuel cell sensor (0-100%)
Life: 1500000 O2% hours
(One year minimum in typical applications)
Interference Gases and Vapours (in 30% Oxygen, 70% Nitrous Oxide)
37
SPECIFICATION - O2 Monitor
Humidity Effects
Sensor output is relatively unaffected by prolonged operation in either high or very low relative
humidity.
If the sensor shows signs of being affected by condensation, dry the sensor with soft tissue.
CAUTION DO NOT use heat to dry the sensor.
Temperature Effects
The sensor has a built-in temperature compensation circuit, and is relatively unaffected by
temperature changes within the operating temperature range given above.
Pressure Effects
The sensor measures O2 partial pressure, and its output will rise and fall due to pressure change
(e.g. changes in barometric pressure, or breathing system pressure).
An increase in pressure of 10% at the sensor inlet will produce a 10% increase in sensor output.
NOTE
Altitude compensation is automatically applied during calibration.
38
5. PRE-OPERATION PROCEDURES
5.1.1 Mounting the Ventilator 1. Verify the drive gas specified for the
ventilator (oxygen or air).
The remote screen is mounted on an Always use the correct drive gas.
adjustable arm, with the control unit
mounted at the rear or side of the 2. Connect the drive gas inlet port on the
anaesthetic machine. rear of the control unit to a dry, oil free
supply.
Option control unit location
Preferably, mount the control unit Supply pressure range:
permanently on the shelf of the anaesthesia 45 to 100 psi
machine or on a strong bracket. This will (3.1 - 6.9 bar, 310 - 689 kPa)
protect the unit from accidental fall and
disconnection of hoses and cables. OXYGEN SUPPLY:
a) O2 cylinder,
To fit the ventilator control unit permanently
b) Anaesthetic machine O2 auxiliary gas
on a mounting bracket: outlet,
1. Align the four mounting feet over the c) O2 pipeline supply from a wall outlet.
mating holes in the bracket.
2. Use the four M4 screws supplied with AIR SUPPLY:
the mounting bracket kit, inserted a) Air cylinder,
through the bracket and rubber feet b) Anaesthetic machine Air auxiliary gas
and screwed into the threaded inserts outlet
in the base of the ventilator. c) Air pipeline supply from a wall outlet.
Only use the screws supplied with
the kit. Supply pressure should be monitored
by a separate means, e.g. pressure
gauge on anaesthetic machine or
Pole-mount type mounting brackets and side supply line.
frame brackets are available from the
manufacturer. NOTE: It is possible to reconfigure the
ventilator for use with a different drive gas
Bellows unit to the gas originally specified. This work
The bellows unit is built into the A200SP must be carried out by an engineer trained
absorber. by the manufacturer.
39
PRE-OPERATION PROCEDURES
3 25 31
23
2 26
24
20 19 30
18
12
4 1
11 10
21
16 27 13
14
28 5 22
26
29
15 17 12
6
9
7
8
Note
1. AV-S has spirometry and oxygen monitor.
2. Interface cabling is shown for connection
to Prima SP2 On/Off switch and A200SP
Bag/Vent switch.
40
PRE-OPERATION PROCEDURES
1. Bellows
2. Ventilator Control Unit
3. Outlets to Anaesthetic Gas Scavenging System (AGSS)
4. Bacterial Filter
5. Absorber valve block
6. Heat and moisture exchanger (a combined unit with a bacterial filter can be used - see 5.1.9)
7. Patient
8. CGO Block on anaesthetic machine (Fresh Gas Supply)
9. Auxiliary Outlet on anaesthetic machine (Drive Gas Supply)
10. Flow sensor - expiratory
11. Flow sensor - inspiratory
12 Connectors - sensor - pressure monitor
13. Expiratory Valve - Absorber
14. Inspiratory Valve - Absorber
15. Inlet - from Ventilator Bellows
16. Connector - Reservoir Bag
17. Inlet - Absorber - Fresh Gas Supply
18. Drive Gas Inlet - Ventilator
19. Drive gas Outlet - ventilator control unit to bellows
20. Outlet - Exhaust Valve
21. Inlet - Bellows Drive Gas
22. Outlet - to breathing system
23. Input socket - Oxygen monitor sensor
24. Input socket - Prima SP interface
(SP on/off switch)
25. Input socket:
(i) A200SP Absorber Bag/Vent control position
(ii) Spirometer sensor signal
26. Interface connections on Prima SP2 and A200SP
27. APL Valve
28. Outlet from APL Valve to AGSS
29. Oxygen sensor
30. Remote screen unit
31. Cable - control unit to screen
41
PRE-OPERATION PROCEDURES
5 8 9 10 11 12 13 14 15
6
3 2 1
7
4
42
PRE-OPERATION PROCEDURES
WARNING
Do not use a scavenging system that restricts drive
gas flow when negative pressure is exerted on it.
Applying negative or positive pressure to the bellows
exhaust port results in positive pressure in the patient
breathing system.
Therefore, the scavenging system must not generate
more than 0.5 cmH2O positive or negative pressure
when connected to the ventilator.
Any problem arising from an improperly functioning
scavenging system is solely the user`s responsibility.
1
5.1.7 Remote Screen
Attach the DVI cable supplied with the screen
between the interface connectors (1) on the rear of
2
the control unit and screen.
WARNING
Check that the cable between the control unit and
remote display screen unit is securely connected
before use.
Always use a cable type recommended by the
manufacturer.
5.1.8 Printer
Attach a printer to the printer port (2) if a printed
output of the ventilator function is required.
43
PRE-OPERATION PROCEDURES
5.1.10 Spirometer
5.1.10.1 Flow sensors fitted to an A200SP
Absorber mounted on a PrimaSP2
44
PRE-OPERATION PROCEDURES
WARNING
The High and Low Airway Pressure Alarms are
important for patient care.
The connection point must be properly
located in the expiratory limb of the breathing
system.
46
PRE-OPERATION PROCEDURES
7
4
6
2
Note that the bellows assembly is built into 1. Remove the adult bellows housing
the A200SP Absorber. For additional (1) - twist carefully counterclockwise
information, please refer to the user manual until the bayonet tabs become free,
for that product. then lift up from the base (2).
Remove the bellows (3).
CAUTION 2. Fit the paediatric adaptor (5) - press
Always ensure correct fitment of bellows (see the adaptor into the ventilator bellows
illustration above), and carry out a full function assembly base (2).
test before clinical use, if a bellows is removed
3. Fit the paediatric bellows (6) to the
and refitted.
adaptor.
Check for correct assembly, as
1. Remove the bellows housing (1). illustrated (4).
Twist carefully counterclockwise until 4. Fit the paediatric bellows housing (7)
the bayonet tabs become free, then lift to the base by pushing down, then
up from the base (2). twisting clockwise until the bayonet
2. Remove the bellows (3). tabs completely engage.
3. Refit the bellows and check for 5. Function test the ventilator - section
correct assembly, as illustrated (4). 5.3.1.
4. Fit the bellows housing by pushing
down, then twisting clockwise until the
bayonet tabs completely engage.
5. Function test the ventilator - section
5.3.1.
NOTE
If there is any malfunction, the ventilator must
NOT be used.
If the problem cannot be rectified, the ventilator
must be checked by an engineer trained by the
manufacturer.
47
PRE-OPERATION PROCEDURES
Alarm System
WARNING
The operation of each alarm function should be verified
daily.
If the audible alarm or the visual display for any alarm
function fails to activate during any alarm condition or
fails to reset after the alarm has been cleared, refer the
unit to an authorised service technician.
Back-up Battery
WARNING
If the internal battery is fully discharged, the ventilator
will not function.
48
PRE-OPERATION PROCEDURES
49
PRE-OPERATION PROCEDURES
Alarms
1. Select STANDBY MODE.
NOTE
If there is any malfunction, the ventilator must
NOT be used.
If the problem cannot be rectified, the ventilator
must be checked by an engineer trained by the
manufacturer.
Bellows
Check the condition of the bellows and
exhalation diaphragm valve.
Note that the bellows assembly is built into
the A200SP Absorber - please refer to the
user manual for this product.
50
PRE-OPERATION PROCEDURES - O2 Monitor
5.3.1 Installation
Fit the probe (A) to the A200SP absorber.
Connect the cable to the input socket (B) on
the back of the AV-S ventilator control unit
WARNING
The sensor contains a small quantity of
electrolyte, classified as a harmful irritant which
is potentially hazardous.
Do not attempt to open a cell.
ALWAYS check the integrity of the sensor
assembly before use.
Once exhausted, the sensor must be disposed A
of according to hospital, local, state and federal
regulations. B
NOTE
To maintain maximum sensor life:
i) always disconnect the breathing circuit after use.
ii) Switch off the anaesthetic machine to cut-off the
basal flow through the system.
Bacterial Filter
Use a breathing system bacterial filter in the
expiratory limb of the breathing circuit to
protect the oxygen sensor (see section 5.1.9).
CAUTION
Replacement/Disposal - always follow the
instructions supplied with the filter, and always
replace at the recommended interval.
5.3.2 Calibration
The new unit must be calibrated before clinical
use.
Thereafter, as a safety precaution, we
recommend calibration of the unit every
time the system is switched on.
51
PRE-OPERATION PROCEDURES - O2 Monitor
8. Scroll to CALIBRATION.
If the menu shows 21% (which indicates
calibration using air), press the navigator
wheel / button (6) to switch to 100%
(calibration using oxygen).
52
PRE-OPERATION PROCEDURES - O2 Monitor
53
6. SERVICE PROCEDURES
Every day:
Pre-use function check
Every week:
Check the condition of the diaphragm valve,
and clean as required.
Every 6 months:
Inspection and Function Check.
Remove patient block assembly and clean.
Check condition of bellows.
Every 12 months:
Repeat six month procedure, plus:
Replace components, including O-seals,
exhaust diaphragm, one way valve.
Preventive maintenance kit available.
Every 2 years:
Repeat 12 month service, plus:
Replace battery.
Every 4 years:
Repeat two-year service, plus:
Replace PCB battery and bellows
diaphragm valve.
54
SERVICE PROCEDURES
Refitting
5. Position the patient block and push
fully into the control unit, ensuring
that the metal tubes (4) are engaged 4
in their unions.
6. Fit the securing knobs (3).
7. Function test the ventilator.
55
SERVICE PROCEDURES
56
7. SERVICE SCHEDULE
2.4 Default selection screen appears and automatically defaults to adult mode in 'Standby'
after approximately eight seconds.
2.6 Check screen is undamaged, display is clear and that the touch sensitive screen
functions are operating correctly.
4.2 Select 'Clock Menu' check date and time are correct.
Year = 2005 - 2099
Month = 1-12 (Jan - Dec)
Date = 1- 31
Hour = 1-23
Minute = 1-59
57
SERVICE SCHEDULE
5.1 Select 'Service Menu' - 'Engineer Menu' - 'Diagnosis Menu'- 'Display Error Log'
6.3 Discard old bellows and replace with new. (every 12 months)
If necessary clean valve seat and valve disc using alcohol wipe.
Do not attempt to dismantle diaphragm assembly.
6.12 Move hand from Inspiratory connector, and occlude drive gas hose at rear of absorber.
Bellows will fall momentarily but then should stop falling.
Note:
Failure of either 6.11 or 6.12 indicates a bellows leak, diaphragm valve leak, drive gas
hose leak or canister leak.
58
SERVICE SCHEDULE
7.7 With patient valve still removed, connect ventilator to power supply, reconnect gas
supply and switch on the unit.
In 'Standby Mode', set inspiratory flow of 5 L/min using front panel settings: 500, 5,
1:1, OFF, 38.
Switch ventilator to 'Volume Mode'
7.8 Connect test gauge to primary regulator test point and check regulator set to 262 kPa
21 kPa (38 psi +/- 3 psi) during inspiratory phase.
If adjustment is necessary, the cover must be removed.
7.9 Connect manometer to output of patient proportional valve (small probe) and check for
90 cmH2O +/- 10% during the inspiratory phase and zero during the expiratory phase.
Adjust secondary regulator as necessary
7.10 During expiratory phase ensure that there is no gas flow from the Drive Gas
connector.
If necessary carry out Drive Gas Valve Offset calibration.
8.2 Check all electrical connections and components for security. (every 12 months)
59
SERVICE SCHEDULE
9.2 Connect the long corrugated hose to the 'Drive Gas Output' connector of vent and the
vent drive gas connector at rear of absorber.
9.3 Connect the pressure tube to 'Patient Pressure' connection on the rear panel of the
control module to the Pressure Sensing port on the rear of the absorber.
9.4 Connect the cable from the 'Interface' connector on the rear panel of the control
module and to the 'Interface' connection on the rear of the absorber.
Connect the cable from the 'Prima Master' connector on the rear panel of the control
module and the rear of the Prima SP anaesthesia.
9.5 Attach the 'Fresh Gas Supply' hose from the absorber to the CGO of the PrimaSP
9.6 Connect a patient breathing circuit to the CO2 absorber and attach the patient
connector to a test lung.
9.7 Connect the Gas Scavenging System to the Exhaust' connector on the rear of the
vent. (If no scavenge system is attached to the rear of the ventilator, a continuous
bleed during the inspiratory phase will be audible)
10.2 Power Off the Anaesthesia machine. Ventilator should switch 'OFF'
10.5 Note: Standby mode is highlighted white in the bottom right of screen.
10.6 Set incorrect rate, i.e. increase Vt, and/or Rate controls.
Check 'Incorrect Rate Or Ratio' displayed on screen and three alarm tones sound.
Do not confirm settings; wait for default values to return.
11.2 Check Vent O2 sensor is inserted into the absorber O2 sampling point.
11.8 Expose both sensors to air and check reading is 21% +/- 2
12.2 Disconnect fresh gas hose from anaesthesia machine Common Gas Outlet.
Switch the Bag/Vent switch to 'Bag' and remove bag from bag arm.
Remove test lung from patient connector if fitted or remove patient circuit.
Ensure scavenging circuit is not connected.
12.4 From menu select 'Oxygen Monitor & Spirometry' - 'Spiro Calibration'.
12.7 Connect short hose between CGO and absorber Expiratory connection.
Connect the absorber Fresh Gas connector to the Bag arm connector to ensure a
closed system.
12.8 Adjust oxygen flowmeter on anaesthetic machine to achieve accurate 10 L/min flow
12.9 Re-enter 'Oxygen Monitor & Spirometry' - 'Spiro Calibration' in menu system.
12.12 Reconnect fresh gas hose, patient circuit and manual bag.
Reset bag/vent switch to 'Vent' position.
61
SERVICE SCHEDULE
SIMV checks
13.5 Switch ventilator to 'Standby'
From the 'Special Modes' menu select SIMV.
13.7 Note: If absorber switch is not enabled in service menu, the message will read 'Switch
absorber to vent position'
Press 'SIMV' once again.
SMMV checks
13.10 Switch ventilator to 'Standby'
From the 'Special Modes' menu select SMMV.
13.12 Note: If absorber switch is not enabled in service menu, the message will read 'Switch
absorber to vent position'
Press 'SMMV' once again.
PSV checks
62
SERVICE SCHEDULE
13.16 Note: If absorber switch is not enabled in service menu, the message will read 'Switch
absorber to vent position'
Press 'PSV' once again.
13.17 Operate Test Lung (by hand) and check that ventilator assistance is given with a
pressure of 4 cmH2O.
14.2 Set 'Vt' to 600 ml, 'BPM' to 10, 'I:E' to 1:2 and 'Pressure Limit' to 80.
63
SERVICE SCHEDULE
14.12 Check the ventilator is operating smoothly, and that the test lung is inflating.
Check that the absorber manometer indicates +/- 5 cmH2O of the system pressure
displayed on the ventilator screen.
15.1 Set ventilator to default settings and ventilate test lung in 'Volume' mode.
15.4 Volume cycle the ventilator, adjust Vt Set to achieve a peak airway pressure of greater
than 30 cmH2O of water.
64
SERVICE SCHEDULE
16.3 Check waveform holds the airway pressure values. (Level display)
A falling display indicates a leak either in the driving circuit, the patient circuit or the
absorber system.
NOTE
65
8. PARTS LIST
041226
041204
O-ring
O-ring
041204 041245 (See Note, above)
O-ring O-ring
IMPORTANT:
1. Discard clear plastic
041222 slotted spacer, if fitted
O-ring 2. Always reassemble
with solid, opaque
spacer.
300580
Diaphragm
300581
One way Valve
Patient Block
66
PARTS LIST
5000492
Arm Assembly
67
PARTS LIST
68
PARTS LIST
69
PARTS LIST
5 019049 M3 X 10 LG Pan HD 3
7 5000489 Chassis Assembly 1
8 5000499 Tray Assembly (Remote) 1
70
PARTS LIST
71
PARTS LIST
72
73
PARTS LIST
74
PARTS LIST
75
PARTS LIST
1 300580 Diaphragm 1
2 300581 One-way valve 1
3 300583 Inline Relief Valve 1
4 5000478 Check Valve Cap 1
5 300593 Taper Adaptor 1
6 300594 Tapered Conn 1
7 5000448 Spring Guide 1
8 5000450 Valve Body 1
9 5000451 Seat Insert 1
10 5000452 Drive Gas Block 1
11 5000453 Valve Base 1
12 0501 O Ring 1
13 01014 M4 X 16 SKT HD Cap Screw Ss 4
14 011169 M4 Skiffy Cap 4
15 019028 M3 X 6 Grub Ss Cup 1
16 019087 M3 X 16 Cap HD Screw 4
17 019128 M4 X 8 Butt HD CHEM BLK 4
18 019153 M4 X 50 Cap Head SS 4
76
PARTS LIST
77
9. APPENDIX
APPENDIX 1
Care of Back-up Battery
CAUTION
Damage may occur if the battery is allowed to remain in a discharged
state.
Never discharge the battery to below 10.2 volts.
Storage Recharge
temperature period
Note
Removal/replacement of battery must only be undertaken by a trained
technician
78
APPENDIX 2
APPENDIX 2
On-screen Menus
NOTE:
79
Menu Structure
O2 Monitor & Spirometry
Waveform
Alarm settings
ALARM MENU
ESCAPE FROM MENU
ALARM MODE : default default / user (Toggle option)
HIGH TIDAL VOLUME: off off / on (Toggle option)
VM MIN: 0.3 L 0.0 - 7.4 (Integer)
VM MAX: 0.9 L 0.1 - 7.5 (Integer)
VT MIN: 300 mL 10 - 1600 (Integer)
VT MAX: 900 mL 20 - 2400 (Integer)
APNOEA ALARM LIMIT: 0.3 cmH2O 0.3 - 3.5 (Integer)
ALARM VOLUME: 50% 50 - 100% (Integer)
Select settings
User Settings ESCAPE FROM MENU
USER1: CCT1
ESCAPE FROM MENU USER2: CCT2
SELECT SETTINGS USER3: CCT3
SAVE SETTINGS USER4: CCT4
BACK LIGHT LEVEL: 50% USER5: CCT5
VOLUME TYPE: tidal ADULT DEFAULT
PAEDIATRIC DEFAULT
Save settings
ESCAPE FROM MENU
USER1: CCT1 CONFIRM: CCT1
USER2: CCT2 CONFIRM: CCT2
USER3: CCT3 CONFIRM: CCT3
USER4: CCT4 CONFIRM: CCT4
USER5: CCT5 CONFIRM: CCT5
Backlight level
0 - 100% (integer)
Volume type
tidal/minute (toggle)
Service
See next page
80
Service
ESCAPE FROM MENU
LANGUAGE: ENGLISH Language pick list
PRINT PATIENT DATA ENGLISH
SERIAL MODE: none ITALIANO
CLOCK MENU TURKCE
UPGRADE MENU POLSKI
AMBIENT PRESSURE: 988 mBar ESPANOL
DISPLAY HISTORY
*SERVICE PIN: 0 Serial mode pick list
*ENGINEER MENU NONE
Philips
SPACELABS
Clock
ESCAPE FROM MENU Clock pick list (integer)
YEAR: 2005 2005 - 2099 (integer)
MONTH: 3 1 - 12 (integer)
DATE: 16 1 -31 (integer)
DOW: 3 1 - 7 (1 = Monday) (integer)
HOUR: 9 0 - 23 (integer)
MINUTE: 57 0 - 59 (integer)
UPDATE CLOCK
DAYLIGHT SAVING: off off / on (toggle option)
Upgrade
ESCAPE FROM MENU
I/O HARDWARE: 2
I/O FIRMWARE: v0.47 [Build 68]
MAIN FIRMWARE: v0.92 [Build 32]
REGISTRATION KEY: unknown
UPGRADE FIRMWARE: unavailable
ADD NEW FEATURE: unavailable
History Display
ESCAPE FROM MENU
MANUFACTURER DATE : 03/03/05
TOTAL HOURS RUN: 100
LAST SERVICE DATE: 13/08/04
HOURS SINCE SERVICE : 100
DRIVE VALVE CYCLES: 1253
PATIENT VALVE CYCLES: 822
CUTOFF VALVE CYCLES: 72
*NOTE
Service PIN
Engineer Menu
81
APPENDIX 3
82
APPENDIX
Altitude Effects
Gas flow measurements are also affected Flow sensor description
by atmospheric pressure, in a linear The microbridge mass airflow sensor
relationship. operates on the theory of heat transfer.
To compensate for altitude effects an Mass airflow is directed across the surface
ambient pressure sensor is available. When of the sensing elements.
the spirometers are calibrated for zero flow Output voltage varies in proportion to the
the ambient pressure is recorded so that mass air or other gas flow through the inlet
the measured volume may be adjusted. and outlet ports of the package.
The measured volume is multiplied by the
ratio of Pamb to Pcal; where Pamb is the The specially designed housing precisely
latest ambient pressure and Pcal is the directs and controls the airflow across the
ambient pressure recorded when the microstructure sense element.
spirometers were calibrated at zero flow. The microbridge mass airflow sensor has a
unique silicon chip based on advanced
Carrier Gas Effects microstructure technology. It consists of a
The effect of air as the dilutent gas is thin-film, thermally isolated bridge structure
different to that of nitrous oxide and as the containing heater and temperature sensing
ventilator includes only an oxygen monitor, elements. The bridge structure provides a
the additional information of gas being sensitive and fast response to the flow of
ventilated is included to increase available air or other gas over the chip.
accuracy.
Dual sensing elements positioned on both
Anaesthetic Agent Effects sides of a central heating element indicate
The addition of anaesthetic agent is known flow direction as well as flow rate.
also to increase the spirometry readings Laser trimmed thick film and thin film
depending on the agent and its resistors provide consistent
concentration by up to approximately 2%. interchangeability from one device to the
Again this minor volume measurement next.
variation is of no known clinical
disadvantage and is therefore not The microbridge mass airflow sensor uses
compensated for other than that due to temperature-sensitive resistors deposited
oxygen variation due to the percentage within a thin film of silicon nitride. They are
change. suspended in the form of two +bridges over
an etched cavity in the silicon.
Water Vapour Effects The chip is located in a precisely
Water vapour volumes in the breathing gas dimensioned airflow channel to provide a
are not detectable in normal breathing repeatable flow response.
system dynamics.
Highly effective thermal isolation for the
Additional Features heater and sensing resistors is attained by
Additional spirometry features available for etching the cavity space beneath the flow
selection by the user are the ability to turn sensor bridges. The small size and thermal
off the automatic compliance and fresh gas isolation of the microbridge mass airflow
compensation and also the feedback sensor are responsible for the extremely
provided by the oxygen monitor. fast response and high sensitivity to flows.
In this event, the ventilator relies on the
basic delivery look up table and the internal Dual Wheatstone bridges control airflow
flow sensor to confirm delivery volumes as measurement - one provides closed loop
near as possible, under the circumstances. heater control, the other contains the dual
Accuracies for spirometry measurement are sensing elements.
>300 ml 20%
>100 ml <300 ml 20%
<100 ml 50%.
83
APPENDIX
5
4.5
4
3.5
Resistance 3
(cmH2O) 2.5
2
1.5
1
0.5
0
0 20 40 60 80 100 120 140
Flow
(L/min)
84
APPENDIX 4
APPENDIX 4
Cleaning A
Outside surfaces and bellows housing
CAUTION
Care must be taken not to allow liquids to run into the control
unit; serious damage may result.
Bellows
As with all elastomers, the bellows material deteriorates
with aging and should be inspected at least every six
months or after 1200 hours of use, whichever comes first.
The bellows must be replaced if it shows signs of aging.
85
APPENDIX 4
NOTE
If excessive contamination is discovered, check that a
bacterial filter is used in the expiratory limb of the breathing
circuit (or an HME at the patient tee-piece).
Refitting
Refit the diaphragm valve assembly to the bellows
base and reassemble the bellows assembly
If a paediatric bellows is fitted, press the adaptor (C)
into the ventilator bellows assembly base, then fit the
bellows.
CAUTION
Always check for correct fitment of the bellows (see
illustration), and function test the ventilator before clinical
use.
Spirometer Sensors
The sensors are built into the A200SP absorber, and
cleaning and sterilisation can only be carried out when
the absorber assembly is removed for cleaning.
For further information please refer to the user
instructions supplied with the A200SP.
86
APPENDIX 4
Sterilisation
CAUTION
To prevent possible damage to components, peak sterilisation temperatures must
not exceed 134oC (275oF) for steam autoclave.
Do not sterilise the ventilator control unit. Apart from the patient block assembly the
internal components are not compatible with sterilisation techniques and may be
damaged.
Packaging
Pack the control unit with material which is permeable to air and steam but has an
effective maximum pore size which is small enough to exclude microbial
contamination.
All wrapping materials must comply with EN 868: Packaging Materials for
Sterilization of Wrapped Goods.
Processing Equipment
The sterilizer must comply with the stated performance class BS 3970 and HTM
2010 and with additional requirements stated in Section D.
If a Porous-load sterilizer is used it must conform to the specifications in EN 285
and the safety specifications in EN 61010: Part 2-041.
Sterilization must be achieved by direct contact with good quality saturated steam .
Post-processing
Following reprocessing the patient block must be kept in a sterile plastic pouch to
avoid being re-contaminated prior to being fitted to the ventilator.
Refit in accordance with section 6.2.5.5. Function test the ventilator before clinical
use - see section 5.2.1.
Item Method
87
APPENDIX 4
Bacterial Filter
Use a breathing system bacterial filter in the expiratory
limb of the breathing circuit to protect the oxygen sensor
(see section 5.1.8).
CAUTION
Replacement/Disposal - always follow the instructions
supplied with the filter, and always replace at the
recommended interval.
WARNING
The sensor contains:
A) A small quantity of electrolyte, classified as a harmful
irritant which is potentially hazardous.
B) Lead
Do not attempt to open a cell.
ALWAYS check the integrity of the sensor assembly
before use.
Once exhausted, the sensor must be disposed of
according to hospital, local, state and federal regulations.
88
APPENDIX 5
APPENDIX 5
Software Upgrade Installation
Procedure
2
Automatic Software Upgrade
Installation
IMPORTANT NOTES:
1. The ventilator must be connected
only to a USB floppy disk drive, as
illustrated.
Use an industry-standard drive for
this application, to avoid data
transfer errors
2. It is not necessary to remove the
cover from the ventilator for the
software to be upgraded
automatically.
3. Do not install the upgrade from a PC,
or USB Memory Stick device 1
5. Disconnect the the floppy disk drive 9. Ensure that any User Datasheet that
cable from the ventilator USB accompanies the upgrade is read and
connector (2) and switch the ventilator understood by the clinicians that will
on. use the ventilator.
89
APPENDIX 6
On-Screen Menus
Menu Switch
To Access: Press the menu switch on the front panel
EXIT MENUS
O2 MONITOR & SPIROMETRY Navigator Wheel and
FRESH GAS COMPENSATION: ON Press Button
SPECIAL MODES
WAVEFORM Turn the wheel to scroll
ALARM SETTINGS through the menus.
GAS MIXTURE: O2+AIR Press the wheel to enter the
USER SETTINGS required sub-menu.
SERVICE MENU Rotate the wheel to change
the value of displayed
To Exit: parameters.
Press the menu switch on the front panel, or, select EXIT Press the wheel to confirm
MENUS and press the navigator wheel. the required value.
90
APPENDIX 6
91
APPENDIX 6
Spirometer Calibration
1. Check the condition of the external E
Spirometer cables and connections.
92
APPENDIX 6
93
APPENDIX 6
Main Menu
EXIT MENUS
O2 MONITOR & SPIROMETRY
LEAK TEST MENU Leak Test
FRESH GAS COMPENSATION: ON
SPECIAL MODES
WAVEFORM
ALARM SETTINGS
ESCAPE FROM MENU
GAS MIXTURE: O2+AIR <START/STOP LEAK TEST>
USER SETTINGS
SERVICE MENU LEAK STATUS: unknown
LEAK LEVEL: 0 mL/min
BSYS COMP 7.0 mL/cmH2O
94
Cat No 52968
Doc No AV-S 0208 SM
June 2008
Manufactured by:
Penlon Limited
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Barton Lane
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OX14 3PH
UK
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